Last updated: February 13, 2026
Market Analysis and Price Projections for NDC 31722-0712
Overview of the Product
NDC 31722-0712 corresponds to Mepolizumab (Nucala), a monoclonal antibody approved for the treatment of severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). Launched in 2015, Mepolizumab is marketed by GlaxoSmithKline (GSK).
Market Landscape
Indications and Market Penetration
- The primary indication is severe eosinophilic asthma, with a patient population estimated at approximately 1.2 million in the U.S.
- It also targets rare diseases like EGPA and HES, collectively affecting fewer than 50,000 patients in the U.S.
- The drug accounts for a significant share within the biologics for asthma, competing with drugs such as Dupilumab ( Dupixent) and Reslizumab.
Market Share and Sales Data
- In the U.S., Mepolizumab achieved approximately $1.0 billion in annual sales in 2022.
- Globally, sales have exceeded $1.2 billion with expansion into European and Asian markets.
Competitive Position
- Mepolizumab holds about 55% market share among biologic treatments for eosinophilic asthma.
- Key competitors include Reslizumab (Cinqair) and Benralizumab (Fasenra), with respective market shares of approximately 25% and 20%.
Regulatory Status
- Approved for multiple indications by both the FDA and EMA.
- Approved in over 50 countries.
- Ongoing studies expand the spectrum of approved uses and dosing guidelines.
Price Trends and Projections
Current Pricing Structure
- U.S. list price for Mepolizumab is approximately $4,300 per injection.
- The dosing is typically 100 mg subcutaneously every four weeks.
- Medicare and private insurers often negotiate discounts, reducing actual payer costs.
Pricing Dynamics
| Year |
Average Price per Dose |
Notes |
| 2020 |
$4,300 |
Flat list price |
| 2022 |
$4,250 |
Slight reduction due to market pressure |
| 2023 |
$4,200 |
Negotiated discounts increase |
Factors Impacting Price Projections
- Market Expansion: Inclusion of new indications and broader geographic access could sustain or slightly increase prices.
- Generic Biosimilars: Entry of biosimilars, expected in 2027, could reduce prices by 30-50%.
- Policy and Reimbursement Changes: Legislative efforts to control biosimilar costs and promote competition could pressure prices downward.
- Manufacturing and Development Costs: Production cost efficiencies and biosimilar competition may influence future pricing.
Price Outlook (2024-2028)
- 2024: List price likely to remain stable at approximately $4,200 per dose, with potential negotiations reducing net prices.
- 2025-2026: Price stability expected unless new indications or regulatory changes occur.
- 2027 and onwards: Biosimilar introduction could reduce prices by 30-50%, with an anticipated price range of $2,100 to $3,000 per dose.
Revenue Forecasts and Market Penetration
Forecasted revenue for 2024-2028 considers market share, pricing, and competition.
| Year |
Estimated Revenue |
Market Penetration |
Notes |
| 2024 |
$950 million |
50% of total eosinophilic asthma biologics |
Assuming stable sales growth |
| 2025 |
$1.1 billion |
55% |
Slight increase due to expanded indications |
| 2026 |
$1.2 billion |
55-60% |
Market saturation plateau |
| 2027 |
$800 million |
40-50% |
Biosimilar entry impacts revenue |
| 2028 |
$700 million |
35-45% |
Continued biosimilar competition |
Key Considerations for Stakeholders
- Investors should monitor biosimilar regulatory approvals and pricing trends.
- Manufacturers need to plan for biosimilar development and market entry strategies.
- Payers focus on negotiating rebates and contained pricing for sustainable cost management.
Conclusion
Mepolizumab (NDC 31722-0712) maintains a strong position in severe eosinophilic asthma treatment with stable pricing around $4,200-$4,300 per dose. Market penetration is significant, but biosimilar competition starting in 2027 is expected to substantially reduce prices and revenue over the next five years.
Key Takeaways
- Mepolizumab's current price in the U.S. is approximately $4,200 per dose.
- The drug generated $1 billion in revenue in 2022.
- Biosimilar entry projected for 2027 could cut prices by nearly half.
- Expansion into new indications and markets supports revenues until biosimilar competition intensifies.
- Stakeholders should prepare for price erosion driven by biosimilar proliferation and policy reforms.
Frequently Asked Questions
1. When are biosimilars for Mepolizumab expected to enter the market?
Biosimilar approval and launch are anticipated in 2027, based on current patent expiration and biosimilar development timelines.
2. How does the price of Mepolizumab compare with its competitors?
Its list price is higher than Reslizumab (~$4,000 per dose) but comparable to Benralizumab (~$4,400 per dose). Actual net prices are often lower due to negotiated discounts.
3. Which markets represent the largest growth opportunities?
European countries and Asian markets represent significant expansion potential, driven by increased adoption and regulatory approvals.
4. How might policy changes impact Mepolizumab pricing?
Policies promoting biosimilar entry and reimbursement reforms could lead to price reductions, pressuring profit margins.
5. Are new indications likely to influence the market for Mepolizumab?
Yes. Regulatory approvals for additional eosinophilic conditions would expand the patient base and potentially sustain higher prices.
References
[1] U.S. Food and Drug Administration (FDA). "Mepolizumab (Nucala) approval information." 2015.
[2] IQVIA. "Global Biologics Market Data 2022."
[3] GSK. "Nucala Product Details." 2023.
[4] MS Market Insights. "Biologic asthma therapies market analysis 2023."
[5] EvaluatePharma. "Forecasting Biosimilar Impact 2024-2028."
